Senior Associate Quality Assurance

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Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Associate Quality Assurance

What you will do

Lets do this! Lets change the world! Provide Quality Assurance oversight for distribution and supply chain operations for commercial and clinical biopharmaceutical products. Ensure compliance to GMP regulations for area operations and associated processes, including warehousing and distribution and inventory management.

Typical tasks include:

• Internal Quality Assurance support for day to day GMP warehouse, dispensing, and inventory management operations

• External Quality Assurance support for Logistics Service Provider problem reports, performance monitoring, temperature excursions, etc.

• Internal Quality Assurance support for Distribution functions in establishment and maintenance of specific product transportation lanes and modalities

• Support investigations/deviation reports (Distribution temperature excursions and deviations)

• Internal Quality Assurance support for creation and revision of GMP procedures and record generation, including document review, approval, and archival

The successful candidate will have experience working in multiple GMP databases

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

• High school/GED + 4 years quality assurance work experience OR

• Associates + 2 years quality assurance work experience OR

• Bachelors + 6 months quality assurance work experience

• Master's

Preferred Qualifications:

• Previous experience in a Quality Assurance role supporting GMP operations

• Previous experience with quality system transactions (SAP, LIMS, Trackwise, Veeva)

• Strong technical writing skills, demonstrated experience creating deviation technical assessments or equivalent

• Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and adhering to good documentation practices.

• Educated in a science field with 2-3 years of experience in GMP/GCP operations or similarly regulated industry

• Proficient with database use, including data input, archival, and query retrieval

• Great attention to detail and high degree of accuracy in task execution and GMP documentation

• Highly effective verbal and written communication skills, strong interpersonal skills

• Ability to complete tasks autonomously, provide updates to area manager, and identify potential issues

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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